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Astellas Seeking Zolbetuximab Approval in CLDN18.2-Positive Gastric Cancers in Japan

NEW YORK – Astellas Pharma on Friday said it is seeking approval from Japan's Ministry of Health, Labor, and Welfare (MHLW) for zolbetuximab as a first-line treatment in patients with advanced HER2-negative gastric or gastroesophageal junction cancer whose tumors express Claudin 18.2 (CLDN18.2).

The drugmaker submitted a new drug application to the MHLW based on data from two Phase III clinical trials, SPOTLIGHT and GLOW. In SPOTLIGHT, Astellas pitted zolbetuximab plus the chemotherapy regimen mFOLFOX6 against placebo plus mFOLFOX6, and in GLOW, the drugmaker pitted zolbetuximab plus the chemotherapy regimen CAPOX against placebo plus CAPOX.

In both trials, the investigational CLDN18.2-targeting agent combined with chemo improved patients' progression-free survival and overall survival versus just chemo.

Tokyo-based Astellas previously said that data from these two trials would support global regulatory submissions for zolbetuximab. The NDA in Japan is Astellas' first publicly announced submission for the drug.